Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry

Aortic Stenosis Clinical Trial

— SAVI TF  

Official title:

Symetis ACURATE Neo™ Valve Implantation Using TransFemoral Access: SAVI TF Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306226
• Other study ID #: 2013-05
• Status: Completed
• First received: September 2, 2014
• Last updated: March 15, 2018
• Start date: September 2014
• Est. completion date: April 2017

Study information

• Verified date: March 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device

Description:

The SAVI TF is s single arm, multicenter, non-randomized and open registry. The purpose of this registry is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System.

The ACURATE neo™ and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis.

The primary objective is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in the first 1000 consecutive patients with severe aortic stenosis treated with the newly marketed device.

The secondary objective is to evaluate adverse events and device performance of the newly marketed device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

1. Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use

2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry

3. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of clinical endpoints (VARC 2)	Mortality; Stroke; Myocardial infarction; Bleeding complication; Acute kidney injury; Vascular complication; Conduction disturbances and arrhythmia; Other TAVI-related complications	Procedure, 7 days or discharge (whichever occurs first), 30 days, 12 months
Other	Procedural success	Procedural success defined as ACURATE neo™ implanted in intended location with: Valve insufficiency < Grade 3; Mean aortic gradient < 20 mmHg; EOA = 1.0 cm2; No valve-in-valve or conversion to surgery performed; No intra-procedure mortality	Post-implantation
Other	Device success	Device success as defined as: ACURATE neo™ implanted in intended location; No impingement of the mitral valve; Normal coronary blood flow; Valve insufficiency < Grade 3; Mean gradient < 20mmHg; EOA = 1.0 cm2; No valve-in-valve or conversion to surgery performed	7 days or discharge (whichever occurs first), 12 months
Other	Functional improvement from baseline as per NYHA Functional Classification at 7 days or discharge (whichever occurs first), 30 days and 12 months follow-up		7 days or discharge (whichever occurs first), 30 days and 12 months follow-up
Primary	Rate of all-cause mortality		30 days